A set of Frequently Asked Questions on GLP is available below
The quality assurance statement should clearly identify the study and include all the types of inspections that are relevant to the study (including inspections performed as part of a study phase(s)). Associated information should include the dates the inspections were performed and the dates inspection results were reported to management, the study director and if applicable the principal investigator. Some monitoring authorities will require the quality assurance statement to include confirmation that facility audits have been performed.
The statement should confirm that the final report reflects the raw data and some monitoring authorities will require this fact to be clearly stated in the statement.
Verification of the study plan by QA personnel should be documented (see OECD Principles on Good Laboratory Practice, Doc. No. 1). This would also apply to study plan amendments. The GLP Principles do not formally require that these verifications are included in the quality assurance statement but this is often the case (posted on 15 July 2014).
The OECD Principles on GLP (Section II, Par. 2.2.1.f) require QA personnel to sign the statement. The Principles do not restrict this responsibility to specific QA employees such as, for example, the manager of a QA department. However, the procedures for compiling the statement and the responsibility for signing the statement should be described in QA procedures (posted on 15 July 2014).
As is the case for all operative procedures covered by the GLP Principles, the QA programme of inspections and audits should be subject to management verification. What constitutes verification will differ from one monitoring authority to another. In some cases verification will include a requirement for the independent inspection of QA activities. In all cases both QA staff and management should be able to justify the methods used for the conduct of the audit programme (posted on 15 July 2014).
National GLP monitoring authorities may request information relating to the types of QA inspections conducted and the dates they were performed and reported to management. They may also request the names of the QA auditors who performed specific activities so that their training records can be reviewed. However, QA inspection findings will not normally be examined by inspectors as this is likely to have a negative impact on the way in which some QA personnel report findings. Nevertheless, some national monitoring authorities may occasionally require access to the contents of inspection reports in order to verify the adequate functioning of QA or to verify that management has received and acted upon reports from QA concerning problems that are likely to seriously affect the quality or integrity of the facility or a study.
Under no circumstances should QA reports be inspected as an easy way to identify inadequacies within the facility or problems associated with a specific study.
Compliance monitoring authority inspectors will need to verify the effectiveness of QA activities as part of the inspection of QA. In order to do this it is highly likely that they will routinely review QA procedures and other supporting records (with the exception of the inspection report). These documents will be used to verify key requirements including the independence of QA from study specific activities, that critical study phases are monitored in accordance with the facility’s policies and that the frequency of audits is sufficient etc. (posted on 15 July 2014).